Lemborexant

Lemborexant is used to treat insomnia (difficulty falling asleep or staying asleep). Lemborexant belongs to a class of medications called hypnotics. It works by slowing activity in the brain to allow sleep.

Lemborexant comes as a tablet to take by mouth. It is usually taken as needed, not more than one time a day, immediately before bedtime. Lemborexant will work faster if it is not taken with a meal or immediately after a meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lemborexant exactly as directed.

You will probably become very sleepy soon after you take lemborexant and will remain sleepy for some time after you take the medication. Plan to go to bed right after you take lemborexant and to stay in bed for at least 7 hours. Do not take lemborexant if you will be unable to go to bed right away and remain asleep for at least 7 hours after taking the medication.

You should be sleeping well within 7 to 10 days after you start taking lemborexant. Call your doctor if your sleep problems do not improve during this time, if they get worse at any time during your treatment, or if you notice any changes in your thoughts or behavior.

Lemborexant may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with lemborexant and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking lemborexant,

• tell your doctor and pharmacist if you are allergic to lemborexant, any other medications, or any of the ingredients in lemborexant tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: Bosentan (Tracleer); bupropion (Aplenzin, Forfivo, Wellbutrin); carbamazepine (Carbatrol, Epitol, Tegretol, others); clarithromycin; chlorzoxazone; efavirenz (Sustiva, in Atripla, in Symfi); etravirine (Intelence); fluconazole (Diflucan); itraconazole (Onmel, Sporanox, Tolsura); medications for anxiety and pain; methadone (Dolophine, Methadose); modafinil (Provigil); ranitidine (Zantac); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives, sleeping pills, and tranquilizers; tricyclic antidepressants such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and verapamil (Calan, Verelan, in Tarka). Your doctor may tell you not to take lemborexant, may need to change the doses of your medications, or monitor you carefully for side effects. Many other medications may also interact with lemborexant, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have narcolepsy (a condition that causes excessive daytime sleepiness). Your doctor will probably tell you not to take lemborexant.

• tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have or have ever had depression; mental illness; thoughts of harming or killing yourself or trying to do so; a problem with heavy snoring; sleep apnea (condition in which breathing briefly stops many times during the night); other breathing problems or lung diseases such as asthma, bronchitis, and emphysema; cataplexy (episodes of muscle weakness that begin suddenly and last for a short time); or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking lemborexant, call your doctor.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking lemborexant.

• you should know that this medication may cause drowsiness, decreased mental alertness, prolonged reaction time, problems with coordination the day after you take it, blurry or double vision, and may increase the risk that you could fall. Take extra care to be sure you do not fall, especially if you get out of bed in the middle of the night. Your ability to drive or operate machinery the day after you take lemborexant may be impaired even if you feel fully awake. Do not drive a car or operate machinery until you know how lemborexant affects you.

• do not drink alcohol during your treatment with lemborexant. Alcohol can make the side effects of lemborexant worse.

• you should know that lemborexant has caused serious or possibly life-threatening sleep behaviors. Some people who took lemborexant got out of bed and drove their cars, prepared and ate food, had sex, made phone calls, sleep-walked, or were involved in other activities while not fully awake. After they woke up, these people were unable to remember what they had done. These activities may occur with lemborexant whether or not you drink alcohol or also take other sleep medications. Call your doctor right away if you have ever had an unusual sleep behavior while taking lemborexant.

Unless your doctor tells you otherwise, continue your normal diet.

• Lemborexant may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • drowsiness

  • tiredness

  • headache

  • vivid, unusual dreams or nightmares

• Some side effects can be serious. If you experience any of these symptoms, stop taking lemborexant and call your doctor immediately:

  • temporary inability to move or talk while you are going to sleep or waking up (sleep paralysis)

  • sudden and temporary weakness of legs

  • new or worsening depression or anxiety

  • thoughts of suicide, dying, or hurting yourself, or planning or trying to do so

  • sudden onset of muscle weakness

  • pounding heartbeat

• Lemborexant may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• drowsiness

Keep all appointments with your doctor.

Do not let anyone else take your medication. Lemborexant is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.